N-RES
Research type
Research Study
Full title
ISO-101 a novel device for the treatment of orthostatic hypotension-a signal of efficacy study
IRAS ID
332168
Contact name
James Frith
Contact email
Sponsor organisation
Isotech Ltd
Duration of Study in the UK
0 years, 6 months, 1 days
Research summary
Orthostatic hypotension (OH) is a very common and debilitating condition, caused by a drop in blood pressure (BP) on standing up. It can cause symptoms such as dizziness, falls and fainting. It affects up to one in five older people, reduces their quality of life and increases their risk of hospitalisation.
There has been very little research on how best to treat this condition but, due to the nature of the condition, medications are not the best option. People with OH have previously reported that they prefer non-drug treatments, but these have poor adherence (e.g. drinking large volumes of water). Activating the muscles during standing is one potential treatment and a device has been invented by the company lsotech Ltd, who specialise in inventing and developing medical devices to improve quality of life. Their new device is worn as a wristwatch which when activated by the patient, causes contraction of muscles which temporarily increases BP, which should help relieve symptoms on standing up and prevent falls and injuries.
This device could dramatically improve the way this condition is managed and could help huge numbers of older people. The researchers aim to include 30 patients with orthostatic hypotension in a study which will take place at Newcastle Upon Tyne NHS Foundation Trust (NuTH). The scope of this project involves executing the first clinical evaluations of prototypes to establish a signal of efficacy.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
23/YH/0202
Date of REC Opinion
13 Sep 2023
REC opinion
Favourable Opinion